IMRT and Timing in Combination With EGFRTKI for Stage IV Non-small-cell Lung Cancer

NCT03258671 | Unknown DMC

• 1 other identifier: CSWOG
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This study is for patients with EFGR gene sensitive mutations diagnosed by pathology or cytology, having a course of chest radiotherapy treatment and molecular Target Therapy for the treatment of stage IV non-small cell lung cancer. Patients with non-small cell lung cancer have a risk of the tumour in the lung recurring or progressing after treatment. In this study, the investigators aim to verify the following hypothesis:

• whether in combination with concurrent or concomitant EGFR-TKI regimen chemotherapy, Intensity Modulated Radiation Therapy can reduce the risk of the tumour in the lung recurring or progressing similarily.
• Intensity Modulated Radiation Therapy concomitant with EGFR-TKI has a better normal tissue dose/volume tolerance than concurrent regimen.
• the survival can be improved by using this new molecular Target-radiotherapy method.

Conditions

Nonsmall Cell Lung Cancer; Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (3)

• Therapeutic efficacy of EGFR-TKI and concurrent/concomitant local RT in NSCLC patients.

  Tumor Response will be evaluated using the RECIST system. Modified WHO criteria will be used for measurement of tumors. The irradiated lesion will be excluded from the assessment of response.

  >4 weeks post treatment

• Overall survival (OS)

  Overall survival is defined as the time interval from date of diagnosis to date of death from any cause

  Up to 5 years

• Progression-free survival (PFS)

  PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive disease (PD) = at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, appearance of one or more non-target lesion(s) and/or unequivocal progression of existing non-target lesions

  Up to 5 years

Secondary Outcomes (4)

• Objective response rate(ORR)

  Up to 5 years

• Disease control rate (DCR)

  Up to 5 years

• Adverse events (toxicities)

  Up to 5 years

• Local regional progression-free survival（LRPFS）

  Time Frame: Up to 5 years

Study Arms (2)

Mutation+ concurrent

EXPERIMENTAL

IMRT concurrent with EGFR-TKI on paticipants with known sensitive EGFR mutations.

Drug: EGFR-TK Inhibitor; Radiation: Intensity Modulated Radiation Therapy

Mutation+ concomitant

EXPERIMENTAL

IMRT concomitant with EGFR-TKI on paticipants with known sensitive EGFR mutations.

Drug: EGFR-TK Inhibitor; Radiation: Intensity Modulated Radiation Therapy

Interventions

EGFR-TK Inhibitor DRUG

·EGFR-TKI：gefitinib will be administered 250mg/d ivgtt qd; icotinib will be administered 150mg/d ivgtt tid;

Mutation+ concomitant; Mutation+ concurrent

Intensity Modulated Radiation Therapy RADIATION

High dose group：DTGTV=70Gy； * first course radiotherapy：40Gy/20f/4w（DTPTV：36Gy/20f/4w）,2Gy/f/d； * late course radiotherapy：1.5Gy/f、2f/d、interval≥6 hs、DTGTV=30Gy（DTPTV=27Gy）。 Low dose group：DTGTV=50Gy; * first course radiotherapy：32Gy/16f/3w（DTPTV为28.8Gy/16f/3w），2Gy/f/d； * late course radiotherapy：1.5Gy/f、2f/d、interval≥6小时、DTGTV为18Gy（DTPTV为16.2Gy）。

Mutation+ concomitant; Mutation+ concurrent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed stage IV NSCLC\[UICC 2017 8th edition\] with known sensitive EGFR mutations(confirmed by tissue or blood).
• Have not received one or more prior treatments
• to 80 years of age.ECOG performance status 0～2 or KPS≥60
• Have distant metastatic lesions≤5；and have clear consciousness when the metastatic sites were brain; and have no influence on pulmonary function when the metastatic sites were lung.
• Have no contraindications in radiotherapy, EGFR-TKI and chemotherapy
• Normal bone marrow and organ function as defined below:
• Absolute neutrophil count ≥ 1,500/mcl Platelets ≥ 100,000/mcl Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 2.0 x IULN AST (SGOT) / ALT (SGPT) ≤ 3.0 x IULN; if liver metastases, ≤ 5.0 x IULN Serum creatinine ≤ 1.5 x ULN LVEF ≥ 50% performed no more than 4 weeks prior to enrollment. FEV1\>50%，mild-moderate pulmonary function dysfunction.
• Able to understand and willing to sign a Human Research Protection Office (HRPO) approved written informed consent document (or that of legally authorized representative, if applicable).
• With good compliance to the treatment and Follow-up

You may not qualify if:

• Evidence of small cell, large cell neuroendocrine or carcinoid histology.
• Non-stage IV NSCLC and ECOG performance status 3～5 or KPS\<60
• Have a serious or uncontrolled medical condition that could compromise the patients' ability to adhere to the protocol.
• Malignant pleural effusion and pericardial effusion
• Uncontrolled intercurrent illness including, but not limited to, hypertension , diabetes mellitus ,ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant and/or breastfeeding: Patient must have a negative pregnancy test within 14 days of study entry.
• Have a secondary malignancy (except adequately treated non-melanomatous skin cancer, or other cancer such as in situ of the cervix. considered cured by surgical resection or radiation). Patients who have had another malignancy in the past but have been disease free for more than 5 years are eligible.
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to EGFR-TKI or other agents used in the study.
• With poor compliance
• The researchers consider it inappropriate to participate in the study

Sponsors & Collaborators

• LuBing: lead

Study Sites (1)

The affiliated hospital of Guizhou medical university

Guiyang, Guizhou, 550004, China

Location

Related Publications (1)

• Li Q, Liang N, Zhang X, Zhang Y, Ouyang W, Su S, Ma Z, Hu Y, Geng Y, Chen X, Lu B. Reasonable Timing of Radiotherapy for Stage IV Non-Small-Cell Lung Cancer During Targeted Therapy Based on Tumour Volume Change. Front Oncol. 2021 Sep 23;11:705303. doi: 10.3389/fonc.2021.705303. eCollection 2021.

  PMID: 34631535 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Lu Bing, Director

  ouyangww103173@163.com

  STUDY DIRECTOR

Central Study Contacts

Lu Bing, Director

CONTACT

86-18275356814; ouyangww103173@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 23, 2017
• Study Start: October 1, 2017
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: August 25, 2017

Record last verified: 2017-08

Locations

CN (1)